Arcus stock tumbles 6% after unveiling casdatifan trial data

Investing.com -- Arcus Biosciences (NYSE: RCUS) shares fell 6% today after the company presented new clinical data for casdatifan, its investigational HIF-2α inhibitor, at an investor event in New York City. The market decline suggests the data did not meet elevated expectations that had been priced into the stock ahead of the event.

The company presented results from its ARC-20 platform study evaluating casdatifan across first-line combinations, second-line treatment, and late-line monotherapy in clear cell renal cell carcinoma. The presentation included progression-free survival figures that exceeded benchmarks for the approved ipilimumab/nivolumab combination and a 50% confirmed objective response rate in the first-line setting.

In the first-line setting, casdatifan plus zimberelimab showed landmark progression-free survival values of 86% and 69% at 6 and 12 months, respectively, in 30 patients with 11.5 months of median follow-up. These figures exceeded benchmarks for pembrolizumab monotherapy and the ipilimumab and nivolumab combination.

The second-line cohort evaluating casdatifan plus cabozantinib in 43 patients demonstrated a 14.5-month median progression-free survival, exceeding benchmarks for cabozantinib monotherapy. The combination showed efficacy in patients who had progressed on prior TKI therapy.

In heavily pre-treated patients, pooled monotherapy cohorts showed a 35-month median overall survival, 13-month median progression-free survival, and 36% confirmed objective response rate. The company stated this exceeded benchmarks for the only approved HIF-2α inhibitor by more than one year.

Arcus said the Phase 3 PEAK-20 study evaluating casdatifan plus ipilimumab and nivolumab is on track to start by year-end. The ongoing Phase 3 PEAK-1 study is evaluating casdatifan plus cabozantinib in the second-line setting.

All cohorts had a data cut-off of Sept. 4, 2026. No unexpected safety signals were observed across the cohorts.

Original Article

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